QUALITY ASSURANCE DOCUMENT CONTROL (QADC) LABELING SPECIALIST
Position is scheduled for 2nd shift Sun-Wed (1pm -11 pm).
This is a 100% onsite position.
- The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records.
- To succeed in this role, you will have a strong attention to detail and an analytical mindset.
- Supports all activities for the Quality Assurance Label Control group.
- Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
- Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
- Coordinates with production teams to ensure timely issuance of labels.
- Performs training of label control and issuance requirements for internal personnel as needed.
- Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc.
- Writes, reviews, and updates SOPs as required.
- Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
- Provides support during internal and health authority inspections and audits of facility.
- Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
- Performs supplemental investigations/projects as required by Management.
- Maintains knowledge of current GMPs and regulatory guidelines.
- Bachelor's degree or equivalent.
- Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
- Some document management experience.
- Crystal reports experience preferred.
- Strong communication and customer service skills.
- Strong computer skills with MS Office (e.g., Word, Adobe, Visio, and Excel) and with Quality Systems (e.g., Document Management System, Quality Management System).
- Develop and improve label issuance processes to drive operational efficiency.
- Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
- Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
- Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
- Possess project management skills.
- Experience interacting with FDA or other regulatory agencies strongly preferred.
- Strong knowledge of cGMPs and domestic regulatory requirements.
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
- Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network.
- Working Conditions (US Only):
- Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts.
- Weekend and off-shift support may be required.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Kevin:
ALPHA'S REQUIREMENT #22-02112
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
- Good Manufacturing Practices
- Product Quality Assurance
- Technical Services
- Raw Materials